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Exploring the Effects of Coenzyme Q10 on Bioenergetics Metabolism in Geriatric Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01390389
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : November 25, 2013
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Bipolar Depression
Intervention: Drug: Coenzyme Q10

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Bipolar subjects were recruited from the McLean Hospital Geriatric Psychiatry Inpatient and Outpatients services, and similar external programs, as well as through radio and internet advertisements. Controls through contacts with the Harvard Division on Aging, local retirement communities and advertisements on the internet, and senior centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who met DSM-IV diagnostic criteria for Bipolar Disorder and were currently depressed episode were assigned to the CoQ10 group. The CoQ10 group was to receive CoQ10 therapy for 4 weeks. Healthy control subjects no evidence of current or past psychiatric disorders were assigned to the Control group. This group did not receive CoQ10 therapy.

Reporting Groups
  Description
Control Healthy controls with no evidence of current or past psychiatric disorders.
CoQ10 Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.

Participant Flow:   Overall Study
    Control   CoQ10
STARTED   10   9 
COMPLETED   6   8 
NOT COMPLETED   4   1 
Withdrawal by Subject                2                0 
Screen Fail                2                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Healthy controls with no evidence of current or past psychiatric disorders.
CoQ10 Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
Total Total of all reporting groups

Baseline Measures
   Control   CoQ10   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   19 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9  90.0%      6  66.7%      15  78.9% 
>=65 years      1  10.0%      3  33.3%      4  21.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (60.2)   63  (50.05)   62.21  (5.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  10.0%      3  33.3%      4  21.1% 
Male      9  90.0%      6  66.7%      15  78.9% 
Region of Enrollment 
[Units: Participants]
     
United States   10   9   19 


  Outcome Measures

1.  Primary:   Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline   [ Time Frame: Baseline ]

2.  Secondary:   To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.   [ Time Frame: 4-week trial ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cara McCabe
Organization: McLean Hospital
phone: 617-855-2410
e-mail: cfmccabe@partners.org



Responsible Party: Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01390389     History of Changes
Other Study ID Numbers: 2011-P-000980
K23MH077287 ( U.S. NIH Grant/Contract )
First Submitted: July 7, 2011
First Posted: July 11, 2011
Results First Submitted: August 26, 2013
Results First Posted: November 25, 2013
Last Update Posted: December 7, 2017